Label: CHILDRENS PAIN AND FEVER- acetaminophen suspension

  • NDC Code(s): 76281-525-23, 76281-525-24
  • Packager: AptaPharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    (in each 5 mL = 1 teaspoonful)
    Acetaminophen 160 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses temporarily ■ reduces fever
    ■ relieves minor aches and pains due to:
    ■ the common cold ■ flu ■ headache ■ sore throat
    ■ toothache

  • WARNINGS

    Warnings
    Liver warning
    This product contains acetaminophen. Severe liver
    damage may occur nyour child takes: ■ more than 5
    doses in 24 hours, which is the maximum daily amount
    ■ with other drugs containing acetaminophen

    Allergy alert: acetaminophen may cause severe skin
    reactions. Symptoms may include: ■ skin reddening
    ■ blisters ■ rash
    If a skin reaction occurs, stop use and seek medical help
    right away.

    Sore throat warning
    If sore throat is severe, persists for more than 2 days,
    is accompanied or followed by ever, headache, rash.
    nausea or vomiting, consult a doctor promptly.

  • DO NOT USE

    Do not use
    ■ with any other drug containing acetaminophen
    (prescription or nonprescription). If you are not sure
    whether a drug contains acetaminophen, ask a doctor
    or pharmacist.
    ■ If your child is allergic to acetaminophen or any other of
    the inactive ingredients in this product.

  • ASK DOCTOR

    Ask a doctor before use if your child has liver disease.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if your child

    is taking the blood thinning drug warfarin.

  • WHEN USING

    When using this product do not exceed

    recommended dose (see overdose warning)

  • STOP USE

    Stop use and ask a doctor if
    ■ pain gets worse or lasts more than 5 days ■ fever
    gets worse or lasts more than 3 days ■ new
    symptoms ■ redness or swelling is present.
    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning:Taking more than the recommended dose (overdose)
    may cause liver damage. In case of overdose, get
    medical help or contact a Poison Control Center right
    away. (1-800-222-1222) Quick medical attention is critical
    for adults as well as for children even if you
    do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ this product does not contain directions or
    complete warnings for adult use.
    ■ shake well before using
    ■ mL = milliliter; tsp = teaspoonful
    ■ find the right dose on the chart below. If possible, use
    weight to dose, otherwise, use age.
    ■ if needed, repeat dose every 4 hours while
    symptoms last
    ■ do not give more than 5 times in 24 hours
    ■ do not give for more than 5 days unless directed
    by a doctor.

     Weight (lb) Age (yr) Dose (mL or tsp)*
     under 24 under 2 years ask a doctor
     24-35 2 - 3 years 5 mL (1 tsp)
     36-47 4 - 5 years 7.5 mL (1 1/2 tsp0
     48-59 6 - 8 years 10 mL (2 tsp)
     60-71 9 - 10 years 12.5. mL (2 1/2 TSP)
     72-95 11 years 15 mL (3 tsp)

    *or as directed by a doctor

    Attention: use only enclosed dosing cup specifically
    designed for use with this product. Do not use any
    other dosing device.


  • OTHER SAFETY INFORMATION

    Other information
    ■ each 5 mL (1 tsp) contains; sodium 3 mg
    ■ store between 20-25ºC (68-77ºF)
    ■ do not refrigerate
    ■ Keep carton for full directions for use.

  • INACTIVE INGREDIENT

    Inactive ingredientsanhydrous citric acid,
    butylparaben, FD&C red #40. flavor, glycerin. high
    fructose corn syrup, microcrystalline cellulose and
    carboxymethylcellulose sodium, propylene glycol.
    purified water. sodium benzoate, sorbitol solution.
    sucralose, xanthan gum

  • QUESTIONS

    Questions? Call weekdays from 9:30 AM to 4:30

    PM EST at 1-877-798-5944

  • Product Label

    AP SAFE®​                   

    COMPARE TO THE

    ACTIVE INGREDIENT IN

    CHILDREN'S TYLENOL

    ORAL SUSPENSION*

    Children's

    Pain

    & Fever

    Acetaminophen

    Oral Suspension

    Pain reliever/Fever Reducer

    • Alcohol-Free
    • Ibuprofen Free
    • Aspirin Free
    • For Ages 2 to 11

    4 FL OZ (118 mL)

    160 mg per 5 mL

    Cherry Flavor

    DO NOT USE IF PRINTED NECK BAND IS
    BROKEN OR MISSINGThis

    Product is not manufactured or distributed
    by McNeil Consumer Healthcare, distributor of
    Children's Tylenol®Oral Suspension.

    Manufactured by:
    AptaPharma Inc.
    1533 Union Ave.
    Pennsauken. NJ 08110

    2 OZ PACKAGE

    525-23 2 Oz Box

    4 OZ PACKAGE

    Carton

    525-24 4OZ Box

    Bottle

    525-24 4OZ BTL

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-525
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-525-241 in 1 CARTON09/30/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76281-525-231 in 1 CARTON09/30/2020
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/21/2013
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-525)